Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aBox 2— 510(k) K240849

Clearance details

Applicant

Ambu A/S

Product code

Code FAJ

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2024-03-27

Decision date

2024-10-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Ballerup, DK

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• K253892 — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable) +3 more2026-04-16
• K253905 — PrimeSight UltraView System2026-04-07
• K260271 — Strauss Surgical cystoscope, hysteroscope and accessories Instruments2026-03-27

• K260578 — Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)2026-07-14
• K251583 — Ambu® Virobac II® Exhalation Filter2026-04-30
• K250269 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection)2025-06-11
• K240848 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aView 2 Advance2024-10-10
• K242108 — Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aView 2 Advance2024-08-16

Injury

533

Malfunction

6,705

Total

7,238

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →